[Federal Register Volume 85, Number 142 (Thursday, July 23, 2020)]
[Notices]
[Pages 44539-44541]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15996]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0490]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Cosmetic Labeling 
Regulations and Voluntary Cosmetic Registration Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 24, 2020.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0599. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Cosmetic Labeling Regulations--21 CFR part 701 and Voluntary Cosmetic 
Registration Program--21 CFR parts 710 and 720

OMB Control Number 0910-0599--Revision

    The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair 
Packaging and Labeling Act (FPLA) require that cosmetic manufacturers, 
packers, and distributors disclose information about themselves or 
their products on the labels or labeling of their products. Sections 
201, 301, 502, 601, 602, 603, 701, and 704 of the FD&C Act (21 U.S.C. 
321, 331, 352, 361, 362, 363, 371, and 374) and sections 4 and 5 of the 
FPLA (15 U.S.C. 1453 and 1454) provide authority to FDA to regulate the 
labeling of cosmetic products. Failure to comply with the requirements 
for cosmetic labeling may render a cosmetic adulterated under section 
601 of the FD&C Act or misbranded under section 602 of the FD&C Act.

I. Cosmetic Labeling Regulations

    FDA's cosmetic labeling regulations are codified in part 701 (21 
CFR part 701). Section 701.3 requires the label of a cosmetic product 
to bear a declaration of the ingredients in descending order of 
predominance. Section 701.11 requires the principal display panel of a 
cosmetic product to bear a statement of the identity of the product. 
Section 701.12 requires the label of a cosmetic product to specify the 
name and place of business of the manufacturer, packer, or distributor. 
Section 701.13 requires the label of a cosmetic product to declare the 
net quantity of contents of the product. The information collection 
provisions found in part 701 are currently approved under OMB control 
number 0910-0027. To improve the efficiency of Agency operations, we 
are consolidating these information collection elements into OMB 
control number 0910-0599.

II. Voluntary Cosmetic Registration Program

    Information collection associated with our Voluntary Cosmetic 
Registration Program (VCRP) are found in parts 710 and 720 (21 CFR 
parts 710 and 720). Participants have the option of submitting 
information via paper forms or via an online interface. The use of the 
term ``form'' refers to both the paper form and the online system.
    Pursuant to part 710, we request that establishments that 
manufacture or package cosmetic products voluntarily register with us 
using Form FDA 2511 entitled ``Registration of Cosmetic Product 
Establishment.'' The online version of Form FDA 2511 is available on 
our VCRP website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp. We encourage online registration of Form FDA 
2511 because it is faster and more efficient for the filer and the 
Agency. A registering facility will receive confirmation of online 
registration, including a registration number by

[[Page 44540]]

email. The online system also allows for amendments to past 
submissions.
    Because registration of cosmetic product establishments is not 
mandatory, voluntary registration provides FDA with the best 
information available about the locations, business trade names, and 
types of activity (manufacturing or packaging) of cosmetic product 
establishments. We store the registration information in a computer 
database and use the information to generate mailing lists for 
distributing regulatory information and for inviting firms to 
participate in workshops on topics in which they may be interested. 
Registration is permanent, although we request that respondents submit 
an amended Form FDA 2511 if any of the originally submitted information 
changes.
    Pursuant to part 720, we request firms that manufacture, pack, or 
distribute cosmetics to file with the Agency an ingredient statement 
for each of their products. Filing of cosmetic product ingredient 
statements is also voluntary. Ingredient statements for new submissions 
are reported on Form FDA 2512, ``Cosmetic Product Ingredient 
Statement,'' and on Form FDA 2512a, a continuation form. Amendments to 
product formulations also are reported on Forms FDA 2512 and FDA 2512a. 
When a firm discontinues the commercial distribution of a cosmetic, we 
request that the firm notify FDA that they have discontinued a cosmetic 
product formulation by submitting an amended Form FDA 2512. If any of 
the information submitted on these forms is confidential, the firm may 
submit a request for confidentiality of a cosmetic ingredient.
    FDA's use of an electronic submission system has been designed to 
make it easier for participants to provide information to FDA about 
their products. The online version of Forms FDA 2512 and FDA 2512a are 
available on our VCRP website at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.
    Description of Respondents: Respondents to this collection of 
information include cosmetic manufacturers, packers, and distributors. 
Respondents are from the private sector (for-profit businesses).
    In the Federal Register of April 3, 2020 (85 FR 18993), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received communicating 
general support for the information collection.
    We estimate the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of                         Average
   21 CFR section; activity        Number of     disclosures per   Total annual     burden per      Total hours
                                  respondents      respondent       disclosures     disclosure
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701.3; ingredients in order of           1,518                21          31,878               1          31,878
 predominance.................
701.11; statement of identity.           1,518                24          36,432               1          36,432
701.12; name and place of                1,518                24          36,432               1          36,432
 business.....................
701.13; net quantity of                  1,518                24          36,432               1          36,432
 contents.....................
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ................  ..............  ..............         141,174
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The estimated annual third-party disclosure burden is based on data 
available to the Agency, our knowledge of and experience with 
cosmetics, and communications with industry. The hour burden is the 
additional or incremental time that establishments need to design and 
print labeling that includes the following required elements: A 
declaration of ingredients in decreasing order of predominance, a 
statement of the identity of the product, a specification of the name 
and place of business of the establishment, and a declaration of the 
net quantity of contents. These requirements increase the time 
establishments needed to design labels because they increase the number 
of label elements that establishments must consider when designing 
labels. These requirements do not generate any recurring burden per 
label because establishments must already print and affix labels to 
cosmetic products as part of normal business practices. We estimate 
that the total third-party disclosure burden is 141,174 hours.

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                                                                              Average
                                                                             Number of       Number of     Total annual     burden per
                 21 CFR section or part                    Form FDA No.     respondents    responses per     responses       response       Total hours
                                                                                            respondent                       (minutes)
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Part 710 (registrations)................................        \2\ 2511           1,702               1           1,702            0.20             340
                                                                                                                                    (12)
720.1 through 720.4 (new submissions)...................        \3\ 2512           6,843               1           6,843       0.33 (20)           2,258
720.6 (amendments)......................................            2512           2,477               1           2,477       0.17 (10)             421
720.6 (notices of discontinuance).......................            2512             232               1             232        0.10 (6)              23
720.8 (requests for confidentiality)....................  ..............               1               1               1               2               2
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............           3,044
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 2511'' refers to both the paper Form FDA 2511 and online Form FDA 2511 in the online system known as the VCRP, which is
  available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.

[[Page 44541]]

 
\3\ The term ``Form FDA 2512'' refers to the paper Forms FDA 2512 and 2512a and online Form FDA 2512 in the online system known as the VCRP, which is
  available at https://www.fda.gov/cosmetics/voluntary-cosmetic-registration-program/online-registration-voluntary-cosmetic-registration-program-vcrp.

    We base our estimate on information from cosmetic industry 
personnel and FDA experience entering data submitted on paper Forms FDA 
2511, 2512, and 2512a into the online system. We estimate that, 
annually, 1,702 establishments that manufacture or package cosmetic 
products will each submit 1 registration on Form FDA 2511, for a total 
of 1,702 annual responses. Each submission is estimated to take about 
0.20 hour per response for a total of 340.4 hours, rounded to 340. We 
estimate that, annually, firms that manufacture, pack, or distribute 
cosmetics will file 6,843 ingredient statements for new submissions on 
Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 
about 0.33 hour per response for a total of 2,258.19 hours, rounded to 
2,258. We estimate that, annually, firms that manufacture, pack, or 
distribute cosmetics will file 2,477 amendments to product formulations 
on Forms FDA 2512 and FDA 2512a. Each submission is estimated to take 
about 0.17 hour per response for a total of 421.09 hours, rounded to 
421. We estimate that, annually, firms that manufacture, pack, or 
distribute cosmetics will file 232 notices of discontinuance on Form 
FDA 2512. Each submission is estimated to take about 0.10 hour per 
response for a total of 23.2 hours, rounded to 23. We estimate that, 
annually, one firm will file one request for confidentiality. Each such 
request is estimated to take 2 hours to prepare for a total of 2 hours. 
Thus, the estimated total reporting burden is 3,044 hours.
    Our estimated burden for the information collection reflects an 
overall increase of 3,044 hours and a corresponding increase of 11,255 
responses. We attribute this adjustment to an increase in the number of 
hours and responses due to the consolidation of OMB control numbers 
0910-0027 and 0910-0599. Total burden for the combined collection of 
information is therefore, 144,218 hours (141,174 hours from OMB control 
number 0910-0599 and 3,044 hours from OMB control number 0910-0027).

    Dated: July 20, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-15996 Filed 7-22-20; 8:45 am]
BILLING CODE 4164-01-P